Infusion pump including pain controlled analgesic (&#34;pca&#34;) apparatus

ABSTRACT

An infusion pump apparatus including a pain controlled analgesic (“PCA”) input device is disclosed. The infusion pump apparatus includes a housing, a pump actuator supported by the housing, and a PCA input device. The infusion pump apparatus also includes electronics configured to control the pump actuator, provide a voltage to the PCA input device, and sense an electrical signal in response to the pain controlled analgesic input device being depressed. The infusion pump apparatus further includes a controller electrically coupled to the electronics and programmed to determine whether the sensed electrical signal is discontinuous, and if the sensed signal is discontinuous, transmit an output indicative of the pain controlled analgesic input device functioning improperly.

PRIORITY CLAIM

This application is divisional of and claims the benefit of and priorityto U.S. patent application Ser. No. 14/832,617, filed Aug. 21, 2015,which is a continuation application of, and claims the benefit of andpriority to U.S. patent application Ser. No. 13/734,445, filed on Jan.4, 2013, now U.S. Pat. No. 9,132,232, which is a continuationapplication of, and claims the benefit of and priority to U.S. patentapplication Ser. No. 13/043,044, filed on Mar. 8, 2011, now U.S. Pat.No. 8,361,010, which is a continuation application of, and claims thebenefit of and priority to U.S. patent application Ser. No. 12/061,496,filed on Apr. 2, 2008, now U.S. Pat. No. 7,914,483, the entire contentsof which is incorporated herein by reference.

BACKGROUND

The present disclosure relates to medication delivery and moreparticularly to delivery of a pain controlled analgesic (“PCA”).

Infusion pumps are used to administer liquid drugs to patients. Theliquid drug is supplied from a source of the drug and delivered to thepatient via a catheter or other injection device. The infusion pumpcontrols the manner in which the liquid drug is infused to the patient.The pump can have various modes of infusion. An infusion pump canoperate in different modes of infusion, such as: (i) a continuous modein which the pump delivers a single volume at a single rate; (ii) anauto-ramp mode in which the pump delivers the liquid drug at a rate thatgradually increases to a threshold rate, remains at the threshold ratefor a period of time, and then gradually decreases; (iii) anintermittent mode in which the pump delivers discrete liquid volumesspaced over relatively long periods of time, such as a liquid volumeevery three hours; (iv) a custom mode in which the pump can beprogrammed to deliver a unique infusion rate at discrete time periods;and (v) a pain controlled analgesic (“PCA”) mode during which the pumpperiodically infuses boluses of an analgesic in response to requests bythe patient.

The PCA delivery has a number of benefits including: (i) a time savingsbetween when the patient feels pain and/or the need to receive analgesiaand when the drug is administered; (ii) a reduction of workload of thenursing staff (an amount of the prescribed analgesic, enough formultiple doses, is pre-loaded into the infusion device and delivered viaPCA mode); (iii) reduction of the chance for medication error (PCAprogrammed per physician's order for amount); (iv) patients receivemedicine when they need it, instead of having to wait for the nursingstaff; (v) patients who use PCA devices have reported better analgesiaand lower pain scores than those patients who have to request analgesiafrom the nursing staff; and (vi) PCA provides a measurement of how muchpain an individual patient is experiencing from one day to the next.

PCA modes of drug delivery involve the intravenous, epidural, orsubcutaneous administration of a liquid opioid. The infusion pumpscurrently in use for PCA in some instances give the clinician twoparameters to set when prescribing a given drug for a patient: (i) adose or bolus amount of drug administered whenever the patient presses abutton and (ii) a lockout interval which determines how soon after abolus is administered that a second bolus can be delivered if thepatient presses the button again. If a patient presses the button beforethe lockout interval has elapsed, the PCA pump ignores the request. Thedose and lockout are programmed into the pump for an individual patientand drug combination. The dose is prescribed based on the clinician'sassessment of the patient's drug or opioid requirement (depending onweight and habituation. The lockout interval is generally set dependingon the time to onset of clinical effect of a given drug. The lockoutinterval is used to prevent a patient drug overdose resulting fromgiving himself or herself another bolus before the previous bolus hashad a chance to take effect.

Sometimes a third parameter is programmed into a pump providing PCA.This is the flow rate of a continuous infusion of medication providing abackground of opioid on top of which PCA is added. The continuousinfusion is adjusted to provide the minimum amount of drug needed by apatient over time. The PCA component then allows the patient toadminister extra (rescue or break-through-pain) doses as needed. Thistechnique of using a continuous infusion along with PCA minimizes therequirement for a patient to push the button repeatedly as a bolus wearsoff. This is particularly useful at night when the patient's sleep wouldotherwise be interrupted regularly.

The PCA button is connected to the infusion pump via a cord. Theinfusion pump supplies an analog voltage to the button. The infusionpump's electronics recognizes a patient's closure of the PCA button bydetecting a change in voltage level, which is normally not seen but seenwhen the button is pressed.

The analog cables can be prone to a number of errors. A frayed wire orwires within the cord may not allow current to flow or enough current toflow to trigger the electronics when the patient pushes the PCA button,rendering the pump unable to deliver a bolus of analgesic, or possiblydelivering a bolus when it is not needed or has not been requested. Or,the wires can become short circuited, damaging electrical components inthe pump or opening a fuse, which may need to be replaced, and may alsolead to improper analgesic dosage delivery.

A need accordingly exists for an improved PCA input apparatus andmethod.

SUMMARY

The present disclosure provides a pain controlled analgesic (“PCA”)apparatus, which is more reliable than current systems.

In one embodiment, an infusion pump is provided that is connected to aPCA input device having one or more button. The device is connected tothe pump's primary housing via a cord. The PCA input device includes aremote microchip or integrated circuit. The chip or circuit communicateswith a local chip or circuit located at the infusion pump. Communicationbetween the remote (button) microchip and local (pump) microchip isperformed digitally and/or through frequency matching. Communicationprotocols such as Inter-Integrated Circuit (“I²C”), Serial PeripheralInterface Bus (“SPI”) (two or three wire), Transistor-Transistor LogicUniversal Asynchronous Receiver/Transmitter (“TTL UART”), or StandardRS232 Universal Asynchronous Receiver/Transmitter (“RS232 UART”) may beused between the remote and local microchips. The type of protocolchosen depends upon the number of wires in the cord. The cord can have,for example, a single fiber optic cable, two wires or three wires, whichare configured to carry low analog voltage, e.g., 3 to 24 VDC, signals.

The remote microchip senses when the one or more PCA button is pressedand sends a corresponding signal to the local microchip. The localmicrochip in turn is connected electrically to the pump's processing andmemory, which causes a pump motor to deliver a bolus of analgesic ifconditions are appropriate to do so, e.g., if the current button presshas not occurred too soon after previous button press.

The digital protocol (digital message protocol or frequency waveform) isconfigured to sense for example when a communication line has beenbroken, e.g., through the lack of response from a handshaking requestfrom the local microchip to the remote microchip. For example, the localmicrochip can be programmed to send a handshake request to the remotemicrochip after a predetermined time interval. If the request is sentand no response is sent back, the local microchip can tell the pumpprocessing and memory that there is a problem with the PCA button. Thelocal microchip can either be programmed to send a second handshakerequest or be told to do so by the pump electronics. If a secondhandshake request is again not answered (second attempt not absolutelynecessary or more than one second request could be made) the infusionpump is configured to take appropriate action.

In one embodiment, appropriate action includes providing an alarm oralert at the pump, e.g., in the form of an audible alarm and a messageon the pump's video screen saying, e.g., “PCA disabled.” Alternativelyor additionally, the pump can be configured to provide a dose ofanalgesic to the patient either at a preset interval and dose or at alast recorded interval and dose. For example, if the alarm is notcleared, e.g., no nurse has responded or the patient is at home andasleep, and a period of time transpires after which the pump should havebeen told to deliver a dose of analgesic, the pump can provide a dose,e.g., prescribed dose of the analgesic and continue to do so at the setintervals until the alarm is cleared.

The above handshaking routine is performed regularly enough in oneembodiment such that a broken or frayed cord is detected before thepatient is likely to press the PCA button. Either the remote or localmicrochip or the pump electronics can be programmed to look for otherPCA input failures, such as failures with the PCA button or switcheswithin the input device housing the button. To this end, any one or moreof the microchips and the pump electronics can have programmableprocessing and memory to detect additional failure modes.

For example, the button of the PCA input device is a momentary button inone embodiment, which the patient need only press for a moment toinitiate delivery of an analgesic bolus. When the patient releases thebutton, a spring pushes the button such that a break in electricalcontact is made. It may happen that the spring does not functionproperly and the button stays depressed after the patient releases thebutton. In such a case, the PCA system of the present disclosure candetect the stuck button in a myriad of ways.

In one way, the remote integrated circuit detects a constant rather thana momentary input from the PCA button. The remote integrated circuit hasprogrammed processing and memory to determine a stuck button condition,the remote integrated circuit sends a “stuck button” message to thelocal integrated circuit, which relays the message to the pump'sprocessing and memory, which alarms and takes other corrective action.

In another way, the remote integrated circuit detects a constant ratherthan a momentary input from the PCA button and relays the constantsignal to the local integrated circuit. The local integrated circuit hasprogrammed processing and memory to determine a stuck button condition,the local integrated circuit sends a “stuck button” message to thepump's processing and memory, which alarms and takes other correctiveaction.

In a further way, the remote integrated circuit detects a constantrather than a momentary input from the PCA button and relays theconstant signal to the local integrated circuit, which in turn relaysthe signal to the pump's processing and memory. The pump's processingand memory has programmed processing and memory to determine a stuckbutton condition and alarms and takes other corrective action.

In another example, the button of the PCA input device is a maintainedbutton, which the patient need only press for a moment to initiatedelivery of an analgesic bolus. When the patient releases the button inthis instance, however, the button remains depressed until anotheraction causes the button to release, e.g., a timer times out or thebolus is competed. Here, the mechanism holding the button in a depressedstate, e.g., against a spring, may have trouble maintaining electricalcontact, causing the button to intermittently make contact or “chatter.”In this case too, the PCA system of the present disclosure can detectthe chattering PCA contact in a myriad of ways by placing the programmedprocessing an memory at the remote integrated circuit, the localintegrated circuit or the pump's processing and memory as describedabove for the stuck PCA button.

In a further example, the wires within the PCA cord can become shortedcausing a false request for a bolus dose. Here, a continuous signal canbe treated the same as a stuck button by placing the programmedprocessing and memory at either the local integrated circuit or thepump's processing an memory. Alternatively, when the local integratedcircuit receives a signal from the remote integrated circuit requestingan analgesic bolus, the local integrated circuit can send a handshakesignal back to the remote integrated circuit for the remote integratedcircuit to confirm. The remote integrated circuit will either not sendthe confirm signal or the shorted lines will impede the signal.

It is accordingly an advantage of the present disclosure to provide animproved infusion pump.

It is another advantage of the present disclosure to provide an infusionpump having an improved pain controlled analgesic (“PCA”) input device.

It is a further advantage of the present disclosure to provide a PCAinput device having diagnostic capability for both the input device andthe cord connecting the input device to the pump housing.

It is yet another advantage of the present disclosure to provide a PCAinput device having open circuit detection capability.

It is yet a further advantage of the present disclosure to provide a PCAinput device having short circuit detection capability.

It is still another advantage of the present disclosure to provide a PCAinput device having button stuck detection capability.

It is still a further advantage of the present disclosure to provide aPCA input device having button chatter detection capability.

Further still, it is an advantage of the present disclosure to providean infusion pump having a PCA input system that can detect when the PCAinput device is not functioning properly and override the PCA inputdevice and provide an analgesic dose automatically.

Additional features and advantages are described herein, and will beapparent from, the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view illustrating one embodiment of an infusionpump of the present disclosure.

FIG. 2 is another perspective view illustrating one embodiment of aninfusion pump of the present disclosure.

FIG. 3 is a schematic view showing one embodiment of a controlarchitecture for the pain controlled analgesia (“PCA”) apparatus of thepresent disclosure.

FIG. 4 is a schematic view illustrating one embodiment for configuringthe integrated circuits disclosed herein with the PCA apparatus of thepresent disclosure.

FIG. 5 is a schematic view illustrating another embodiment forconfiguring the integrated circuits disclosed herein with the PCAapparatus of the present disclosure.

FIG. 6 is a chart showing different embodiments for communicationbetween the integrated circuits and pump control of the presentdisclosure.

FIG. 7 is a logic flow diagram illustrating one frayed cord or opencircuit method of operation for the PCA apparatus of the presentdisclosure.

FIG. 8 is a logic flow diagram illustrating one crossed-wire or shortcircuit method of operation for the PCA apparatus of the presentdisclosure.

FIG. 9 is a logic flow diagram illustrating one stuck button method ofoperation for the PCA apparatus of the present disclosure.

FIG. 10 is a logic flow diagram illustrating one chattering contactmethod of operation for the PCA apparatus of the present disclosure.

DETAILED DESCRIPTION

Referring now to the drawings and in particular to FIGS. 1 and 2, anembodiment of an infusion pump 10 having the microchip based paincontrolled analgesic (“PCA”) apparatus of the present disclosure isillustrated. Infusion pump 10 includes a housing 12. In the illustratedembodiment, housing 12 of infusion pump 10 has a generally contouredshape. Housing 12 can have other shapes if desired.

The housing 12 includes a first member 14 and a second member 16 thatare connected together to form a central cavity 18. Central cavity 18houses various components of the pump 10 including the user interface20. The first member 14 of the housing has an opening 22 thataccommodates a display screen of the user interface 20. A rear portionof the housing 12 has a receptacle or recess 24 that is adapted toreceive a power supply 26. At a bottom, front portion of the housing 12,a container compartment or syringe compartment 28 is defined thataccommodates a syringe assembly 30, a portion of a drive mechanism 40and other components. The first member 14 of the housing 12 has a hingedaccess door 32 that encloses syringe assembly 30 in compartment 28.Access door 32 can be transparent for medical personnel to view thecontents within syringe assembly 30.

A lock 34 is provided with door 32 to prevent unauthorized access tosyringe assembly 30. An upper portion of the housing 12 is provided witha handle 36. Housing 12 can be made from a variety of materialsincluding various types of plastics and metals. Housing 12 has a poleclamp 38 attached to the second member 16 of the housing 12. Pole clamp38 can have various designs and is adapted to mount pump 10 on a poleassembly used in a hospital setting. In one embodiment, pole clamp 38can mount pump 10 in various positions. For example, the pump 10 can bemounted in a generally horizontal position shown in FIGS. 3A and 3B ofU.S. Pat. No. 7,018,361 (“the '361 patent”) entitled “Infusion Pump”,the entire contents of which are incorporated herein by reference.

FIG. 2 shows syringe compartment 28 in greater detail. Syringecompartment 28 is dimensioned to receive and support the syringeassembly 30 and receive a portion of drive mechanism 40. Syringeassembly 30 includes a syringe barrel 42 and a syringe plunger 44.Syringe barrel 42 contains medication and slidably receives the syringeplunger 44. Drive mechanism 40 drives syringe plunger 44 to forcemedication from the syringe barrel 42 through a tube (not shown) and toa patient. The tube has one end connected to an end of the syringebarrel 42 and another end configured to be connected to a patient.

The syringe compartment 28 has a rear wall 46 that is generally concaveto receive the syringe barrel 42 of the syringe assembly 30. The syringebarrel 42 of the syringe assembly 30 and rear wall 46 are generally inconfronting relation. The housing 12 further has a curved lip 48 that inone embodiment is integral with the rear wall 46. Lip 48 aids in loadinga syringe 26 in the compartment 28 to be described in greater detailbelow. As shown in FIG. 2, a syringe clamp 50 is movably mounted in thecompartment 28. The clamp 50 has a concave inner surface that faces therear wall 46 and that fits over the syringe barrel 42. Clamp 50 isslidable along a rod assembly (see number 54 at FIG. 18 of the '361patent) to move the clamp 50 towards and away from the rear wall 46. Theclamp 50 can slide along the rod assembly 52 to accommodate differentsized syringe barrels. A base portion of the clamp 50 has a pair ofrollers 54, 56 that help reduce friction when the clamp 50 slides alongthe housing 12. Due to tolerances, the clamp 50 may also pivot slightly.Clamp 50 is resiliently biased towards rear wall 46.

Housing 12 and syringe compartment 28 are sized such that an entiresyringe assembly, with plunger fully extended from the syringe barrel,is contained within the housing and can be enclosed by the access door32. No part of a syringe barrel or syringe plunger protrudes from thehousing 12. A portion of the drive mechanism 40 extends into the syringecompartment 28 to engage the plunger 44. Access door 32 has an openingthat accommodates the tube (not shown) that is attached to the syringebarrel 42 to deliver medication to the patient.

As shown in FIG. 1, pump 10 has a user interface 20. Portions of theuser interface 20 are described in greater detail in commonly owned U.S.patent application Ser. No. 10/172,808 (2004-0225252) entitled “SystemAnd Method For Operating An Infusion Pump”, the entire contents of whichare incorporated herein by reference. User interface 20 includes adisplay screen 58, a first control panel 60, a second control panel 62and associated electrical components and computer software containedwithin the housing 12 to operate the pump 10. Display screen 58 displaysall of the general operating parameters of the pump 10 and fits withinthe opening 22 in the housing 12.

The display screen 58 in one embodiment operates with a touch screenoverlay for a user to enter data to be into the pump 10. As discussed,the pump 10 can be mounted in either a generally horizontal position ora generally vertical position. The software associated with the userinterface 20 and pump 10 has the ability to display information on thescreen 58 in either a landscape orientation or a portrait orientation.When the pump is mounted in the horizontal configuration information isdisplayed on the display screen 50 in a landscape configuration. Whenpump 10 is mounted in the vertical configuration, information isdisplayed on the display screen 50 in a portrait configuration. Thus,depending on how the pump 10 is mounted, the information can be read byusers without the need to tilt one's head. This feature is described ingreater detail in commonly-owned U.S. Pat. No. 6,997,905 entitled“Dual-Orientation Display For Medical Devices”, the entire contents ofwhich are incorporated herein expressly by reference. First controlpanel 60 has a start button 64, a stop button 66 and an alarm/alertbutton 68. Second control panel 62 has a settings panel 70, a historybutton 72 and a data port 74. Pump 10 also includes a radio frequencyidentification (“RFID”) reader 76, which reads a radio frequency(“RFID”) tag 78 placed on syringe barrel 42. Data port 74 in oneembodiment is an infrared data port, which communicates with a personaldata assistant (“PDA”) 80 operated by a nurse or clinician.

The pump 10 provides patient-controlled analgesia (“PCA”). As shown inFIG. 2, pump 10 includes a PCA input device 100, which allows thepatient to manually actuate the pump actuator to deliver a bolus ofanalgesic to the patient when desired and when proper. PCA input device100 is connected via a cord 102, which is plugged into or otherwiseconnected to housing 12 of pump 10. PCA input device 100 in oneembodiment includes a peripheral structure that protects againstinadvertent actuation. The PCA input device 100 and/or cord 102 can alsobe lighted so as so glow in the dark to aid patients in locating thebutton. PCA input device 100 includes a button 104, which can be amomentary or maintained button as discussed in detail below.

Referring now to FIG. 3, one embodiment for an electrical layout forpump 10 as it relates to PCA input device 100 is illustrated. Pump 10includes a plurality of processors, which can be a master processor(e.g., a central processing unit) running a plurality of delegateprocessors. Pump 10 can also include a safety processor to provideredundancy and ensure proper operation of the other processors. Centralprocessing and memory 106 in one embodiment oversees the pump actuatorprocessing and memory 108, which in turn controls the movement of drivemechanism 40 that drives syringe plunger 44 to force medication from thesyringe barrel 42 through the syringe plunger.

It should be appreciated that while a syringe pump is illustrated, pump10 can be a peristaltic pump, a micro-pump, a piezoelectric pump, eachcapable of delivering a medical fluid to a patient. Accordingly, whilethe source of the drug or medicament is shown as being syringe barrel42, the source is alternatively a bag or other medical fluid container.Still further alternatively, pump actuator processing and memory 108 inan alternative embodiment are integrated with central processing andmemory 106.

Pump actuator processing and memory 108 likewise communicates with alocal PCA controller 110. Communication between actuator processing andmemory 108 and local PCA controller 110 can be via a protocol, such asInter-Integrated Circuit (“I²C”), Serial Peripheral Interface Bus(“SPI”) (two or three wire), Transistor-Transistor Logic UniversalAsynchronous Receiver/Transmitter (“TTL UART”) and Recommended Standard232 Universal Asynchronous Receiver/Transmitter (“RS232 UART”). In asimilar manner, local PCA controller 110 can communicate with remotecontroller 112 via a protocol, such as Inter-Integrated Circuit (“I²C”),Serial Peripheral Interface Bus (“SPI”) (two or three wire),Transistor-Transistor Logic Universal Asynchronous Receiver/Transmitter(“TTL UART”), Recommended Standard 232 Universal AsynchronousReceiver/Transmitter (“RS232 UART”) and fiber optic cable. As seen inFIG. 3, local PCA controller 110 is separated from remote PCA controller112 via cord 102. The signals between controllers 110 and 112 can be lowvoltage analog, e.g., zero to five VDC or 4 to 20 milliamp, signals.

Remote controller 112 operates with PCA input device 100 to receive aninput from the patient when the patient presses button 104 to receive abolus of analgesic. When button 104 of PCA input device 100 is pressed,remote integrated circuit or microchip 112 sends a digital message tolocal integrated circuit or microchip 110. As shown below, localintegrated circuit or microchip 110 can also send a digital message toremote integrated circuit or microchip 112 either by way of response orto initiate a handshake or other desired back-and-forth with remoteintegrated circuit or microchip 112. Remote integrated circuit ormicrochip 112 can also respond to a digital message sent from localintegrated circuit or microchip 110.

Referring now to FIGS. 4 and 5, two different configurations for theremote and local controllers 110 and 112, relative to PCA cable 102, PCAinput device 100 and housing 12 of pump 10 are illustrated. FIG. 4illustrates one embodiment in which local integrated PCA circuit 110 ishoused within housing 12 of pump 10 and remote integrated PCA circuit112 is located within a housing 114 of PCA input device 100. Remotecontroller 112 can include at least one integrated circuit chip ormicrochip 116, such as an off the shelf, low power utilization,electronic microchip. Remote controller 112 is shown connected to button104 via wires 120 a. Alternately, button 104 includes a contact thatmates with a contact located directly on remote controller 112, makingseparate wires unnecessary. Remote controller 112 is also connectedelectrically to wires 120 b of cord 102. Wires 120 a and 120 b connectto microchip 116. Microchip in one embodiment includes onboardprocessing and memory. However, processing and memory external tomicrochip 116 could be used alternatively. Traces 122 a formed on aprinted circuit board (“PCB”) 124 a connect microchip 116 to wires 120 aand 120 b and associated downstream components.

Cord 102 is connected to housing 12 of pump 10 via an electrical fitting126. Local controller 110 can include at least one off of the shelfintegrated circuit chip or microchip 118, which also has onboardprocessing and memory (processing and memory are alternativelyexternal). Local controller 110 is connected electrically to wires 120 bof cord 102. Wires 120 c connect local controller 110 to actuatorprocessing and memory 108 (FIG. 3). Wires 120 b and 120 c connect tomicrochip 118 via traces 122 b formed on a PCB 124 b, to which microchip118 is also soldered. Local controller 110 is located alternatively on asame PCB as actuator processing and memory 108 (FIG. 3) and communicateswith actuator processing and memory 108 via circuit board traces. Cord102 in the illustrated embodiment is a three-wire cord but alternativelyhas a different number of wires 120 b if needed.

In the alternative embodiment of FIG. 5, cord 102 incorporates localcontroller 110 and remote controller 112 into connectors 126 a and 126 bof the cord, which in turn connect cord 102 respectively to PCA device100 and pump 10. Remote controller 112 of connector 126 a of FIG. 5 caninclude at least one integrated circuit chip or microchip 116. Remotecontroller 112 is shown connected to button 104 via wires 120 a. Remotecontroller 112 is also connected electrically to wires 120 b of cord102. Wires 120 a and 120 b connect to microchip 116 via traces 122 aformed on a printed circuit board (“PCB”) 124 a to which microchip 116is soldered.

Local controller 110 of connector 126 b of FIG. 5 can include at leastone integrated circuit chip or microchip 118. Local controller 110 isconnected electrically to wires 120 b of cord 102. Wires 120 c connectlocal controller 110 to actuator processing and memory 108 (FIG. 3).Wires 120 b and 120 c connect to microchip 118 via traces 122 b formedon a PCB 124 b to which microchip 118 is soldered.

FIG. 6 illustrates, without limitation, three processing scenarios forlocal controller 110 and remote controller 112. Three functionsseparating the three processing scenarios include (i) signal processing,(ii) data manipulation, and (iii) pump actuation and alert generation.In the first scenario, local controller 110 and remote controller 112are both configured to pass signals to each other. Local controller 110is configured to send and receive signals from actuator processing andmemory 108 (FIG. 3).

In the first scenario, local controller 110 and remote controller 112 donot perform any data manipulation such as add, subtract and/ormanipulate the data as set forth below in the algorithms of FIGS. 7 to10. Here, actuator processing and memory 108 performs theabove-mentioned data manipulation and controls the pump to deliver ananalgesic bolus or causes an alert to be sounded, whichever is needed.Here, remote controller 112 senses an input, e.g., press of button 104,sends a corresponding signal to local controller 110, which relays thesignal to actuator processing and memory 108, which in turn controls thepump to deliver an analgesic bolus or causes an alert to be sounded,whichever is needed.

In the second scenario, local controller 110 and remote controller 112are both configured to pass signals to each other. Local controller 110is configured to send and receive signals from actuator processing andmemory 108 (FIG. 3). In the second scenario, remote controller 112 isconfigured to perform data manipulation such as add, subtract and/ormanipulate the data as set forth below in the algorithms of FIGS. 7 to10. Here, remote controller 112 senses an input, e.g., press of button104, remote controller 112 manipulates data to determine when an alarmneeds to be generated or the pump is to be actuated. Remote controller112 sends a corresponding signal to local controller 110, which relaysthe signal to actuator processing and memory 108, which in turn controlsthe pump to deliver an analgesic bolus or causes an alert to be sounded,whichever is needed.

In the third scenario, local controller 110 and remote controller 112are both configured to pass signals to each other. Local controller 110is configured to send and receive signals from actuator processing andmemory 108 (FIG. 3). In the second scenario, local controller 110 isconfigured to perform data manipulation such as add, subtract and/ormanipulate the data as set forth below in the algorithms of FIGS. 7 to10. Here, remote controller 112 senses an input, e.g., press of button104, and sends a corresponding signal to local controller 110. Localcontroller 110 manipulates data to determine when an alarm needs to begenerated or the pump is to be actuated. Local controller 110 sends acorresponding signal to actuator processing and memory 108, which inturn controls the pump to deliver an analgesic bolus or causes an alertto be sounded, whichever is needed.

Referring now to FIG. 7, an algorithm 130 stored at any of localcontroller 110, remote controller 112 and actuator processing and memory108 illustrates one embodiment in which the PCA system of the presentdisclosure is configured to determine when cord 102 has become frayed.Upon starting at oval 132, algorithm 130 sets a counter N=0. Localcontroller 110 is configured to send periodically, e.g., everyhalf-minute, minute or multiple of a minute, a handshake request toremote controller 112, as seen at block 136. If remote controller 112sends a response to the handshake request to local integrated circuit,meaning proper communication exists between the two controllers (cord isnot frayed), as determined at diamond 138, algorithm 130 waits for thenext time to send a handshake request, as seen at block 140, sets Nagain to zero, and sends another request at block 136. The loop betweenblocks 134 and 136, diamond 138 and block 140 continues until ahandshake response is not sent, as determined at diamond 138.

It should be appreciated that if cord 102 becomes frayed right after thehandshake response is sent and the patient at that second presses button104 for a bolus of analgesic, algorithm 130 will do nothing until thetimer times out at block 140. Although the scenario above is unlikely,it is still desirable to make the time to next request at block 140relatively small. This way, when cord 102 becomes frayed, only a fewseconds or a minute has to pass before such fray is detected. It shouldalso be appreciated that the handshake request can be sent instead fromremote controller 112 to local controller 110, which sends the handshakeresponse back to remote controller 112. Algorithm 130 will operateequally as well.

When a handshake response is not sent, as determined at diamond 138,algorithm 130 advances a counter to N=N+1, as seen at block 142. Thecounter serves as a double, triple or multiple check that the cord isactually frayed. Determining if N=trigger amount at diamond 144 providesa redundant check. Setting N=3 at diamond 144 for example looks to seeif handshake is missing over three cycles and so on. If N is not yetequal to the set trigger amount as determined at diamond 144, algorithm130 is configured to send another handshake request at block 136. If ahandshake response is now sent as determined at diamond 138 the count iscleared back to zero at block 134. If a handshake response is again notsent as determined at diamond 138, N is increased again at block 142.

When N reaches the trigger amount at diamond 144, algorithm 130 assumesthat cord 102 has become frayed, severed or otherwise inoperable. Atblock 146, an “open circuit” alert is sent to actuator processing andmemory 108. It should be appreciated that the counting feature could beleft out of algorithm 130, so that an open circuit is determined after afirst time there is no response to a handshake request. Actuatorprocessing and memory 108 provides an audio, visual or audiovisual alertat pump 10, a remote location or both asking the patient or clinician tocheck cord 102, as seen at block 148.

Another optional feature is shown at diamond 150. Pump 10 in oneembodiment records the time between the last two analgesic bolusdeliveries. Thus pump 10 knows when the next analgesic bolus is likelyto be requested. Pump 10 in one embodiment provides an automatic bolusafter the last recorded period of time passes, after the last recordedperiod of time plus an additional time amount passes, or after apredetermined period of time passes. In algorithm 130, if the alert oralarm is cleared before the next bolus time occurs, as determined atdiamond 150, it is assumed that the frayed cord 102 has been swapped outor that the patient otherwise has an avenue to receiving an analgesicbolus, and algorithm 130 ends as seen at oval 154. In algorithm 130, ifthe alert or alarm is not cleared before the next bolus time occurs, asdetermined at diamond 150, a bolus of analgesic is providedautomatically to the patient as seen at block 152, after which algorithm130 ends as seen at oval 154.

Referring now to FIG. 8, an algorithm 160 stored at any of localcontroller 110, remote controller 112 and actuator processing and memory108 illustrates one embodiment in which the PCA system of the presentdisclosure is configured to determine when cord 102 has a short circuit,e.g., insulation on wires 120 b is missing so that two wires becomeconducting. Algorithm 160 starts at oval 162 when it is assumed that thepatient has pressed bolus button 104 to request a bolus of analgesic. Acorresponding signal is sent from remote controller 112 to localcontroller 110, as seen at block 164. At block 166 local controller 110sends a confirm request signal to remote controller 112.

If a confirm signal is not sent back from remote controller 112 to localcontroller 110, as determined at diamond 168, the local integratedcircuit sends a “short circuit” signal or output to actuator processingan memory 108, as seen at block 170, which provides an audio, visual oraudiovisual alert at pump 10, a remote location or both alerting thepatient or clinician that a short circuit condition has likely occurredand to check cord 102, as seen at block 172. A failed confirm can stemfrom the confirm request signal not reaching the remote controller 112or from the remote controller 112 receiving the request but not beingable to respond to the local controller 110.

If a confirm signal is sent back from remote controller 112 to localcontroller 110, as determined at diamond 168, the local integratedcircuit sends a “provide bolus” signal or output to actuator processingan memory 108, as seen at block 174, which causes the pump actuator toprovide a bolus of analgesic to the patient as seen at block 176. Thus,if after a bolus request, the two controllers 110 and 112 are able tocommunicate, the request is seen as a legitimate request from thepatient instead of a short circuit between wires of cords. If after thebolus request, however, the two controllers 110 and 112 are not able tocommunicate, the request is seen as stemming from some sort of shortcircuit between the wires of cord 102 that have inadvertently caused abolus request signal to be sent. Algorithm 160 then ends as seen at oval178.

Referring now to FIG. 9, an algorithm 180 stored at any of localcontroller 110, remote controller 112 and actuator processing and memory108 illustrates one embodiment in which the PCA system of the presentdisclosure is configured to determine when button 104 of PCA inputdevice 100 has become stuck. In one embodiment, button 104 is amomentary pushbutton which only has to make an electrical contact for ashort period of time for remote controller 112 to sense an input fromthe patient and send a bolus request signal. Here, button 104 includes aspring that unmakes electrical contact when the patient removes his orher thumb or finger from button 104. Momentary button 104 can becomestuck such that the electrical contact is not un-maid when the patientreleases from button 104.

Algorithm 180 starts at oval 182 when the patient presses button 104 anda request for analgesic bolus is sensed at block 184. Upon sensing therequest signal, algorithm 180 starts a timer “t” at block 186. If timed“t” is greater than an expected time t_(expected) as determined atdiamond 188, a “stuck button” alert is provided, which can be an audio,visual or audiovisual alert at pump 10, a remote location or both, whichalerts the patient or clinician that a stuck button condition has likelyoccurred, as seen at block 190.

If however timed “t” is not greater than an expected time t_(expected)as determined at diamond 188, algorithm 180 determines if the bolusrequest signal has stopped as determined at diamond 192. If the timersignal has not stopped, timing continues at block 186 and the loop ofblock 186, diamond 188 and diamond 192 continues until timed “t” isgreater than an expected time t_(expected) (diamond 188) or the requestsignal stops (diamond 192).

If the request signal stops as determined at diamond 192 before timed“t” reaches t_(expected), the bolus of analgesic is delivered to thepatient as seen at block 194. Here, the momentary signal stops before astuck or sticking bolus button 104 is detected. Upon sounding the alertor providing the analgesic bolus, algorithm 180 ends as seen at oval196.

Referring now to FIG. 10, an algorithm 200 stored at any of localcontroller 110, remote controller 112 and actuator processing and memory108 illustrates one embodiment in which the PCA system of the presentdisclosure is configured to determine when button 104 of PCA inputdevice 100 has a chattering contact. In one embodiment, button 104 is amaintained pushbutton, which when pressed stays depressed until anotherevent occurs, e.g., another button is pressed or a timer times out.Maintained button 104 when depressed can have a contact that chattersback and forth instead of making steady contact.

Algorithm 200 starts at oval 202 when the patient presses button 104 anda request for analgesic bolus is sensed at block 204. If the signalsensed is fragmented or not continuous, as determined at diamond 206, a“chattering contact” alert is provided, which can be an audio, visual oraudiovisual alert at pump 10, a remote location or both, which alertsthe patient or clinician that the button 104 is not functioningproperly, as seen at block 208. If however the request signal iscontinuous or non-fragmented, as determined at diamond 206, the bolus ofanalgesic is delivered to the patient as seen at block 210. Uponsounding the alert or providing the analgesic bolus, algorithm 200 endsas seen at oval 212.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows: 1: An infusion pump apparatuscomprising: a housing; a pump actuator supported by the housing; a paincontrolled analgesic (“PCA”) input device; electronics configured tocontrol the pump actuator, provide a voltage to the PCA input device,and sense an electrical signal in response to the pain controlledanalgesic input device being depressed; and a controller electricallycoupled to the electronics and programmed to (i) determine whether thesensed electrical signal is discontinuous, and (ii) if the sensed signalis discontinuous, transmit an output indicative of the pain controlledanalgesic input device functioning improperly. 2: The apparatus of claim1, wherein the output indicative of the pain controlled analgesic inputdevice functioning improperly is (a) audible, (b) visual, or (c)audible/visual. 3: The apparatus of claim 1, wherein the outputindicative of the pain controlled analgesic input device functioningimproperly includes a message indicative of a chattering contact alert.4: The apparatus of claim 1, wherein the controller is a localcontroller, and which includes a remote controller configured tocommunicate with the local controller, the remote controller configuredto receive the electrical signal in response to the pain controlledanalgesic input device being depressed. 5: The apparatus of claim 4,wherein the remote controller includes an electrical contact forcontacting a button of the pain controlled analgesic input device. 6:The apparatus of claim 1, wherein the controller is programmed totransmit the output to a location remote from the infusion pump housing.7: The apparatus of claim 1, wherein the electronics are configured tosense the electrical signal by detecting a change in voltage level fromthe voltage provided to the PCA input device. 8: The apparatus of claim1, wherein the electronics and the controller are located on a printedcircuit board. 9: The apparatus of claim 1, wherein the controller isprogrammed to cause the pump actuator, via the electronics, to provide abolus of analgesic if the sensed signal is determined to be continuous.10: The apparatus of claim 1, further comprising a cord configured tocommunicatively couple the PCA input device to the controller. 11: Aninfusion pump apparatus comprising: a pump actuator; an electricalinterface communicatively coupled to a pain controlled analgesic (“PCA”)input device via a cord; electronics configured to control the pumpactuator, provide a voltage to the PCA input device via the electricalinterface, and sense an electrical signal received at the electricalinterface from the PCA input device in response to the pain controlledanalgesic input device being depressed; and a controller electricallycoupled to the electronics and programmed to (i) determine whether thesensed electrical signal is discontinuous, and (iii) if the sensedsignal is discontinuous, transmit an output indicative of the paincontrolled analgesic input device functioning improperly. 12: Theapparatus of claim 11, further comprising a user interfacecommunicatively coupled to the controller and configured to display theoutput indicative of the pain controlled analgesic input devicefunctioning improperly. 13: The apparatus of claim 12, wherein theoutput indicative of the pain controlled analgesic input devicefunctioning improperly includes a chattering contact alert. 14: Theapparatus of claim 11, wherein the controller is programmed to transmitthe output to a location remote from the infusion pump housing. 15: Theapparatus of claim 11, wherein the electronics are configured to sensethe electrical signal by detecting a change in voltage level from thevoltage provided to the PCA input device. 16: The apparatus of claim 11,wherein the controller is programmed to instruct the electronics tocause the pump actuator to provide a bolus of analgesic if the sensedsignal is determined to be continuous. 17: An infusion pump methodcomprising: providing, via electronics of the infusion pump, a voltageto a PCA input device; sensing, via the electronics, an electricalsignal in response to the pain controlled analgesic input device beingdepressed; electronically determining, via a controller of the infusionpump, whether the sensed electrical signal is discontinuous; and if thesensed electrical signal is discontinuous, electronically sending, viathe controller, an output indicative of the pain controlled analgesicinput device functioning improperly. 18: The method of claim 17, whereinthe output indicating that a button of the pain controlled analgesic isfunctioning improperly is (a) audible, (b) visual, or (c)audible/visual. 19: The method of claim 17, further comprisingtransmitting, via the controller, the output to a user interface of theinfusion pump. 20: The method of claim 17, further comprisingtransmitting, via the controller, the output to a location that isremote from the infusion pump. 21: The method of claim 17, furthercomprising causing, via the controller, a pump actuator of the infusionpump to provide a bolus of analgesic if the sensed signal is determinedto be continuous.